Impact of remote management using patient-reported outcomes on pain and anxiety after breast biopsy: the BIO-PSY randomized controlled trial.
8 affiliations
- 1Department of Palliative and Supportive Care, Montpellier Cancer Institute (ICM), University of Montpellier, 208 Avenue Des Apothicaires, 34298, Montpellier, France. [email protected].
- 2Laboratory Epsylon, EA4556, University Paul Valéry, Montpellier, France. [email protected].
- 3Department of Palliative and Supportive Care, Montpellier Cancer Institute (ICM), University of Montpellier, 208 Avenue Des Apothicaires, 34298, Montpellier, France.
- 4Laboratory Epsylon, EA4556, University Paul Valéry, Montpellier, France.
- 5Biometrics Unit, Montpellier Cancer Institute (ICM), University of Montpellier, Montpellier, France.
- 6Department of Clinical Research and Innovation, Montpellier Cancer Institute (ICM), University of Montpellier, Montpellier, France.
- 7Department of Radiology, Montpellier Cancer Institute (ICM), University of Montpellier, Montpellier, France.
- 8PINKCC Laboratory, INSERM U1194, Montpellier Cancer Research Institute, University of Montpellier, Montpellier, France.
Abstract
Purpose
Although breast biopsy is a routine procedure, it often triggers significant pain and anxiety. Pre-procedural distress has been associated with increased pain and discomfort, and persistent post-biopsy distress may affect psychological and treatment-related outcomes. However, post-biopsy care still lacks standardized follow-up. This study evaluated whether remote monitoring using patient-reported outcomes (PROs) triggering targeted interventions could improve pain and anxiety management after breast biopsy.Methods
BIO-PSY was a French, monocentric, open-labelled, randomized controlled trial. Patients aged ≥ 18 years undergoing breast biopsy were randomized (1:1:1) to daily phone-based PROs (phone contact with a psycho-oncologist for 3 days), e-PROs (electronic interface for 3 days), or standard care. Alerts generated based on PROs thresholds prompted tailored interventions. The primary endpoint was pain on day 4 (0-10 numerical rating scale, phone-assessed). Secondary outcomes included pain at day 10; anxiety and perceived aesthetic impact (days 4 and 10); insomnia (Insomnia Severity Index) at day 10; and strategies for symptoms management.Results
Among 193 patients, pain was negligible (median = 0), stable, and not statistically different between arms at day 4 and 10 (p > 0.05). The proportion of patients with clinically significant anxiety was lower in the experimental arms than in the control arm at day 4 (p < 0.001) and was lower at day 10 only in the phone-based PRO arm (adjusted p = 0.008).Conclusion
Pain after breast biopsy was well controlled across all arms. Remote monitoring using PROs may reduce anxiety, especially with human intervention, supporting its integration into routine post-biopsy care.Clinical trial registration
NCT04456920 (registered on June 23, 2020).
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BibTeX
@article{guerdoux2026impact,
title = {{Impact of remote management using patient-reported outcomes on pain and anxiety after breast biopsy: the BIO-PSY randomized controlled trial.}},
author = {Estelle Guerdoux and Louise Coutant and Anas Al Herk and Laetitia Meignant and Guillaume Laffargue and Fanny Salasc and Jade Pibre and Stéphanie Blasco and Nolwenn Bignon and Muriel Thomaso and Stéphanie Nougaret},
journal = {Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer},
year = {2026},
month = oct,
doi = {10.1007/s00520-026-11349-8},
url = {https://europepmc.org/article/MED/42911430},
note = {CC BY-NC-ND},
}
RIS
TY - JOUR
TI - Impact of remote management using patient-reported outcomes on pain and anxiety after breast biopsy: the BIO-PSY randomized controlled trial.
AU - Estelle Guerdoux
AU - Louise Coutant
AU - Anas Al Herk
AU - Laetitia Meignant
AU - Guillaume Laffargue
AU - Fanny Salasc
AU - Jade Pibre
AU - Stéphanie Blasco
AU - Nolwenn Bignon
AU - Muriel Thomaso
AU - Stéphanie Nougaret
PY - 2026
DA - 2026/10/22
JO - Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer
DO - 10.1007/s00520-026-11349-8
UR - https://europepmc.org/article/MED/42911430
AB - Purpose Although breast biopsy is a routine procedure, it often triggers significant pain and anxiety. Pre-procedural distress has been associated with increased pain and discomfort, and persistent post-biopsy distress may affect psychological and treatment-related outcomes. However, post-biopsy care still lacks standardized follow-up. This study evaluated whether remote monitoring using patient-reported outcomes (PROs) triggering targeted interventions could improve pain and anxiety management after breast biopsy.Methods BIO-PSY was a French, monocentric, open-labelled, randomized controlled trial. Patients aged ≥ 18 years undergoing breast biopsy were randomized (1:1:1) to daily phone-based PROs (phone contact with a psycho-oncologist for 3 days), e-PROs (electronic interface for 3 days), or standard care. Alerts generated based on PROs thresholds prompted tailored interventions. The primary endpoint was pain on day 4 (0-10 numerical rating scale, phone-assessed). Secondary outcomes included pain at day 10; anxiety and perceived aesthetic impact (days 4 and 10); insomnia (Insomnia Severity Index) at day 10; and strategies for symptoms management.Results Among 193 patients, pain was negligible (median = 0), stable, and not statistically different between arms at day 4 and 10 (p > 0.05). The proportion of patients with clinically significant anxiety was lower in the experimental arms than in the control arm at day 4 (p < 0.001) and was lower at day 10 only in the phone-based PRO arm (adjusted p = 0.008).Conclusion Pain after breast biopsy was well controlled across all arms. Remote monitoring using PROs may reduce anxiety, especially with human intervention, supporting its integration into routine post-biopsy care.Clinical trial registration NCT04456920 (registered on June 23, 2020).
SN - 0941-4355
SN - 1433-7339
ER -